Identifiers
- 510(k) Number
- K151860 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Introducing the Infinity CentralStation Wide, a innovative cardiovascular monitoring device designed to provide accurate and timely patient feedback for clinicians. With its advanced algorithms and user-friendly interface, this device helps ensure timely treatment and reduces readmission rates. Our solution is engineered with the latest advancements in medical technology, offering unparalleled performance and reliability.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151860 | Class II | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA 510(k) K151860 24 fields · synced Oct 6, 2026